Scientist, Bioanalytical Sciences
Core
Technical subject matter expert for outsourced bioanalytical methods, ensuring method validation and performance at CROs for PK/TK studies.
Role type
Senior IC bioanalytical scientist (outsourced methods oversight)
Builds
Validated bioanalytical assays (PK/TK) for oncology, inflammation, general medicine, and rare disease therapies
Domain
Biopharmaceuticals / Bioanalysis / Pharmacokinetics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Method development, method validation, troubleshooting, quantitative ligand-binding assays (LBA), LC-MS bioanalysis, regulatory compliance (GLP/GCP), CRO management, assay lifecycle management
Preferred skills
PK assay development expertise, regulatory guidance knowledge (FDA/ICH/EMEA/NMPA), project management, process management, cross-functional collaboration
Technologies
ELISA, ECL, LC-MS/MS, hybrid methodologies
Responsibilities
Lead transfer and validation of PK assays at external CROs, monitor assay performance and troubleshoot issues, review validation plans and reports for regulatory compliance, support supplier evaluation and monitoring activities, collaborate with internal experts on critical assay attributes
Seniority
Senior, hands-on IC
